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news.Alkermes has announced that its partner, Johnson & Johnson Pharmaceutical Research & Development has submitted a supplemental new drug application for Risperdal Consta to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder.
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The supplemental new drug application (sNDA) is based on results from a recent study comparing patients who received Risperdal Consta and standard treatment to those who received standard treatment combined with placebo.
The study found that patients with frequently relapsing bipolar disorder (FRBD) had a significant delay in the time to an initial relapse when Risperdal Consta was combined with standard treatment.